PURPOSE: SA14-14-2 live attenuated Japanese encephalitis (JE) vaccine has been administered safely and effectively to more than 100 million children in China since 1988, and recently licensure of the vaccine in Korea has been sought. Immune response to the vaccine was investigated. MEHTODS: In the first clinical evaluation of the vaccine outside of China, we monitored side effects in 93 children and evaluated plaque reduction neutralizing test (PRNT) antibody and IgM antibody responses to a single dose given as primary JE vaccination in 74 children, 1-3 years old (mean age 27 months). RESULTS: No significant adverse events were noted. PRNT antibodies (geometric mean titer [GMT] of 183) were produced in 96% of the 74 subjects. In 10 other children who previously had been immunized with two or three doses of inactivated JE vaccine, the booster administration of SA14-14-2 vaccine produced an anamnestic response in all, with a GMT of 3378. In a comparison group of 25 children previously immunized with two doses of inactivated vaccine, neutralizing antibody titers were detected in 16 (64%). Viral specific IgM was detected in nine primary vaccinees (13%) but in others, IgM may have declined to undetectable levels in the four week postimmunization sample. CONCLUSION: Live attenuated SA14-14-2 JE vaccine is a promising alternative to the only commercially available live attenuated JE vaccine for national childhood immunization programs in Asia.
Antibodies ; Antibodies, Neutralizing ; Antibody Formation ; Asia ; Asian Continental Ancestry Group* ; Child ; China ; Encephalitis, Japanese* ; Humans ; Immunization Programs ; Immunoglobulin M ; Korea ; Licensure ; Vaccination